NCT02463019

Brief Summary

This open-label study is an roll-over extension of a randomized trial "Efficacy of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients with High Viral Load but Slight Aminotransferase Elevation" (NCT01522625). After finishing the 3-year therapeutic trial, all patients receive open-label TDF for another 3 years. All patients undergo liver biopsy to evaluate the stage of fibrosis after the 3-year open-label therapy. During the 3-year period, patients were followed up every 12 weeks for the biochemical, serological, virological parameters, and adverse reactions. The primary outcome is the progression of liver fibrosis. Safety issues such as change of renal function and bone mineral density are 2nd outcomes.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

4 years

First QC Date

May 14, 2015

Last Update Submit

June 2, 2015

Conditions

Chronic Hepatitis BAntiviral Treatment

Keywords

hepatitis B virustenofovir

Outcome Measures

Primary Outcomes (1)

  • Change of liver histopathology

    evaluated by Knodell and Ishak scoring system

    3 years

Secondary Outcomes (2)

  • Virological response

    3 years

  • Drug resistance

    3 years

Study Arms (1)

Tenofovir

OTHER

Tenofovir Disoproxil Fumarate 300mg daily for 3 years

Drug: Tenofovir Disoproxil Fumarate

Interventions

Tenofovir Disoproxil FumarateDRUG

Tenofovir Disoproxil Fumarate

Also known as: Viread
Tenofovir

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all participants should have finished the clinical trial \<Efficacy of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients with High Viral Load but Slight Aminotransferase Elevation\> without drop-out.
  • willingness to adhere to treatment and follow-up plans

You may not qualify if:

  • co-infection with HIV, HCV, or HDV
  • presence of cirrhosis on histopathology
  • hepatic decompensation defined as serum bilirubin \> 2mg/dl and prolonged prothrombin time \> 3 seconds
  • concurrent malignant diseases including hepatocellular carcinoma
  • severe co-morbidity with life expectancy \< 1year
  • pregnant or lactating women
  • organ transplantation except cornea or hair transplant
  • suspected or confirmed chronic liver diseases from etiologies other than HBV (e.g. alcoholic hepatitis, Wilson disease, Hemochromatosis…etc)
  • serum creatinine \>1.5mg/dL
  • refusal to undergo liver biopsy
  • lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hsu YC, Chen CY, Tseng CH, Chen CC, Lee TY, Bair MJ, Chen JJ, Huang YT, Chang IW, Chang CY, Wu CY, Wu MS, Mo LR, Lin JT. Antiviral therapy for chronic hepatitis B with mildly elevated aminotransferase: A rollover study from the TORCH-B trial. Clin Mol Hepatol. 2025 Jan;31(1):213-226. doi: 10.3350/cmh.2024.0640. Epub 2024 Oct 17.

    PMID: 39415599DERIVED

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis B

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jaw-Town Lin, MD., PhD

    Fu Jen Catholic University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2015

First Posted

June 4, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

June 4, 2015

Record last verified: 2015-06